Power Dental U.S.A. Inc.

Address:2809 Barney Ct,McHenry,IL,60051,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

INSTRUMENT, MANUAL, SURGICAL, GENERAL USE (MDM) (6) Headlamp, operating, battery-operated (HPP) (2) DRILL, DENTAL, INTRAORAL (DZA) (1) SCALER, PERIODONTIC (EMN) (1)

Premarket Exempt

Yes

Clear

Power Dental U.S.A., Inc. - D943N78260 Catalog Number : N7826-0

Device Description : "C&L SINUS KIT, CRESTAL & LATERAL UNIVERSAL KIT

Device Class : 1

Duns Number: 081305064

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : No

Device Count : 1

Power Dental U.S.A., Inc. - D943N78261 Catalog Number : N7826-1

Device Description : 7826-1 BONE PACKER / DEPTH GAUGE 1.00 / 2.20mm

Device Class : 1

Duns Number: 081305064

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : No

Device Count : 1

Power Dental USA - D943N7827 Catalog Number : N7827

Device Description : SURGICAL DRILL POINT PILOT 1.1 x 17mm ( 3 - 6 - 9 -12mm )

Device Class : 1

Duns Number: 081305064

Premarket Exempt : Yes

Product Code : DZA

Prescription Use : No

Device Count : 1

Power Dental U.S.A., Inc. - D943N8001 Catalog Number : N8001

Device Description : POWER FULL EQUIPMENT PERFECT SETTING (1 SUITCASE)

Device Class : 1

Duns Number: 081305064

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : No

Device Count : 1

Power Dental U.S.A., Inc. - D943N8001S00 Catalog Number : N8001S

Device Description : 2 LED HANDPIECE, STERILIZABLE ALL IN ONE, COMPLETE WITH CORDS

Device Class : 1

Duns Number: 081305064

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : No

Device Count : 1

Power Dental U.S.A., Inc. - D943N88611 Catalog Number : N88611

Device Description : DUSA #5755, Small Disc(19mm) Guard with Adapter

Device Class : 1

Duns Number: 081305064

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : No

Device Count : 1

Power Dental U.S.A., Inc. - D943N88612 Catalog Number : N88612

Device Description : DUSA #5756, Large Disc(22mm) Guard w/Adapter

Device Class : 1

Duns Number: 081305064

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : No

Device Count : 1

Power Dental USA - D943N9028SCGS00 Catalog Number : N9028-SCGS

Device Description : SCALER & CURETTE SET OF 6

Device Class : 1

Duns Number: 081305064

Premarket Exempt : Yes

Product Code : EMN

Prescription Use : No

Device Count : 1

Power Dental USA - D943NDKLAMP00 Catalog Number : NDKLAMP

Device Description : Headlamp Full Kit

Device Class : 1

Duns Number: 081305064

Premarket Exempt : Yes

Product Code : HPP

Prescription Use : No

Device Count : 1

Power Dental USA - D943NDKLAMP1 Catalog Number : NDKLAMP-1

Device Description : 1.5 mm lens/loupe

Device Class : 1

Duns Number: 081305064

Premarket Exempt : Yes

Product Code : HPP

Prescription Use : No

Device Count : 1

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